VA Portland Health Care System

Institutional Review Board

Research Project Finalization Report

Federal guidelines require a final report upon the finalization of a human subjects research study
Principal Investigator (PI):
Study Coordinator/Contact Person: / Email: / Date:
Project Title:
Study ID #:

Please request finalization ONLY if:

1) All research-related interventions and/or interactions with human participants have been completed; and

2) Data collection and analysis of identifiable private information is completed. Analysis of de-identified data may continue after study closure.

Note: Current VA regulations require that all research records, including identifiable data and identifying links to data be retained indefinitely. Therefore, if you would like to de-identify the data and continue to conduct data analysis, please:

·  Deliver hard copies of linking documentation in a VHA Internal Privacy Act/HIPAA Envelope to Sharon Jacky in Building 101, Room 502, or send it in an encrypted email to if it is available only in an electronic format.

·  Please note, by submitting this finalization report you attest that this is the only copy of the linking documentation, all others copies have been destroyed, and any further link back to a participant is impossible. Do not delete your electronic copies of the linking documentation until you have received confirmation from the VAPORHCS Research Office that it has been received.

·  Note that this will finalize the study from the perspective of the IRB, and oversight of the study will continue by the R&D Committee (or other applicable subcommittee) until all data analysis (including analysis of de-identified data) is complete.

*If the study is being closed and data analysis will not continue, linking documentation is not required to be submitted to the ACOS/R&D. However, the information must be retained per current VA regulations.

1. Briefly explain why the study is being finalized:

2. a. Did this study obtain informed consent?

Yes No – the requirement for the consent process or documentation of consent was waived.

If “No,” skip to 2.h.

b.  What was the total number of participants consented at the VAPORHCS over the life of the project?

c.  How many participants did the IRB approve to be consented?

d.  If 2b is greater than 2c, explain why:

e.  Of those listed in 2.b, what was the total number enrolled into the study at the VA?

f.  How many participants did the IRB approve to be enrolled?

g.  If 2e is greater than 2f, explain why:

h.  How many participants/medical records/biosamples were included in the study without the consent process and/or documentation of consent?

i.  How many participants/medical records/biosamples did the IRB approve for the research study at the VAPORHCS that did not require either the consent process or documentation of consent?

j.  If 2h is greater than 2i, explain why:

Yes / No
3.  Have progress notes been entered in CPRS, if applicable, for each participant indicating termination of their participation in the research study?
N/A (progress notes were not required for this study)
4.  Did any participants withdraw from the study or complain about the research process?
5.  Were any participants withdrawn from the research project by the Investigator?
Yes / No
6.  Have any reportable events (as outlined on the Reportable Event Form) unanticipated problems and/or serious adverse event(s) occurred since the last IRB review? If NO, skip to 7.
a.  If YES to 6, has the IRB received, reviewed, and approved the event(s)?
If YES, please attach a copy of your most recently approved Human Research Event Report or Reportable Events Forms (whichever applies to this study).
If NO, please add the event(s) to the Human Research Event Report (if one was previously created for this study) or begin a Reportable Events Form and submit the applicable report with this finalization report.
7.  Have any protocol deviations/unanticipated problems/serious adverse events that did not meet the threshold for reporting or have not been reported since initial approval?
If YES to 7, please attach a summary of all events (since initial approval) that did not meet the threshold for reporting or have not been previously reported.
8.  Did any research subjects claim injury from participating in this research project?
If questions 4, 5, 6, or 7 were answered YES, and this was not previously submitted to the VAPORHCS IRB, describe in detail the circumstances; do not include any subject names or PHI. If it was previously submitted, indicate the dates the reports/items were reported to the IRB:
9.  Were all protocol versions, consent forms and other amendments previously reviewed by the IRB?
If NO to 9, please submit any that were not previously submitted to the IRB, as a modification, and report any such occurrence as an event on the Human Research Event Report Form (if one was previously created for this study) or begin a Reportable Events Form and submit the applicable report with this finalization report; all forms are available on the R&D Service website: http://www.portland.va.gov/Research/piservices/rd_forms.asp/.
10.  Will data analysis continue with de-identified information at the VAPORHCS?
If YES to 10, attach the e-mail confirming that the linking documentation has been received by the VAPORHCS Research Office (per the instructions on the first page), or identify the date that the hard copy of linking documentation was submitted to the VAPORHCS Research Office and to whom, or where, specifically it was submitted:
11.  Did this study include analysis of specimens which were sent to a non-VA facility and then either the remainder was returned to the VA or destroyed by that non-VA facility?
If YES to 11, please provide either confirmation that all remaining specimens were returned to the VA or attach a certification from the non-VA facility that the remaining specimens were destroyed, either as certification of destruction of each individual specimen or for the batch of specimens as a whole.
12.  Provide a brief (three sentences or less), lay language summary of the results/findings to date for the study:
13.  Please indicate here whether information about findings (either good or bad) should be disclosed to participants in the study, including the rationale for the determination and, if applicable, the method of notification to participants:
14.  Originals of all hard copies of data/forms/etc for VA Research must be retained at the VA at the time a study is finalized. In addition, a full electronic copy of any electronic records must be behind the VA firewall. Can you provide an assurance that these items are at the VA/behind the VA firewall?
If NO to 14, when will that transfer occur and how will an assurance be provided to the Research Office that it has occurred?
15.  Will funding for this study continue after IRB finalization or is there another component (such as wetlab work, work with animals, etc.) that will continue after IRB finalization?
If YES to 15, explain what component of the study will continue after IRB finalization:
Note that if you answered YES to 15, this study will remain open under the R&D Committee (or other subcommittee) and continuing reviews for that committee will still be required.

Retain a copy of this document in your study records -1- Rev. 2/21/17

Project Finalization Report

I:\OHSU\Public|Irb\Pipacket\finalterm.wpd 6/2000